Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01306721
• Collaborator: (none)
• Enrollment: 520
• Locations: 3
• Arms: 3
• Duration (Months): 1.9
• Patients Per Site: 173.3
• Patients Per Site Per Month: 89.4

Study Details

Study Description

Brief Summary

Primary Objective:

• To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg - pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg - pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60) in patients with seasonal allergic rhinitis (SAR).

Secondary Objectives:

• To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily activity impairment.

• To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis Seasonal	Drug: fexofenadine HCL (M016455); Drug: pseudoephedrine; Drug: fexofenadine HCL matching placebo; Drug: pseudoephedrine matching placebo	Phase 3

Detailed Description

The study duration for each patient is 3 weeks and 3 days:

1. Lead-in period: 1 week

2. Treatment period: 2 weeks

3. Follow-up period: 3 days

Study Design

• Study Type: Interventional
• Actual Enrollment: 520 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Parallel Group Study for Assessing the Efficacy and Safety of a Twice-daily Fexofenadine HCl 60 mg - Pseudoephedrine HCl 60 mg Combination or Fexofenadine HCl 60 mg - Pseudoephedrine HCl 120 mg Combination Versus Allegra® 60 mg in Patients With Seasonal Allergic Rhinitis
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FEX 60 mg Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination)	Drug: fexofenadine HCL (M016455); Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine; Pharmaceutical form:tablet Route of administration: oral; Drug: fexofenadine HCL matching placebo; Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine matching placebo; Pharmaceutical form:tablet Route of administration: oral
Experimental: FEX 60 mg/PSE 60 mg Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination Double-blind treatment period: 1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination)	Drug: fexofenadine HCL (M016455); Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine; Pharmaceutical form:tablet Route of administration: oral; Drug: fexofenadine HCL matching placebo; Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine matching placebo; Pharmaceutical form:tablet Route of administration: oral
Experimental: FEX 60 mg/PSE 120 mg Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg	Drug: fexofenadine HCL (M016455); Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine; Pharmaceutical form:tablet Route of administration: oral; Drug: fexofenadine HCL matching placebo; Pharmaceutical form:tablet Route of administration: oral

Outcome Measures

Primary Outcome Measures

1. Changes in the nasal congestion score based on the patient's symptom diary [over 2 treatment weeks (from baseline to end of treatment)]

Secondary Outcome Measures

1. Changes in the total score of 4 symptoms, each nasal symptom (sneezing, rhinorrhea, and nasal congestion) and eye symptom [over 2 treatment weeks (from baseline to end of treatment)]

2. Changes in total score of 4 symptoms on a daily, day-time, and night-time bases [over 2 treatment weeks (from baseline to end of treatment)]

3. Changes in each symptom (sneezing, rhinorrhea, nasal congestion, and eye symptoms) score and the daily activity impairment score [over 2 treatment weeks (from baseline to end of treatment)]

4. Changes in each symptom score and the daily activity impairment score on a daily, day-time and night-time basis [over 2 treatment weeks (from baseline to end of treatment)]

5. Nasal findings [over 2 treatment weeks (from baseline to end of treatment)]

6. Patient's impression [over 2 treatment weeks (from baseline to end of treatment)]

7. Patient's safety [over 2 treatment weeks (from baseline to end of treatment)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms during the season when cedar pollen levels are increased for at least 2-years

Exclusion criteria:

• At the start of the placebo lead-in period:

• Patients who are negative for IgE Antibody test

• Expected nasal congestion score is less than 2

• The last 3 days of the lead-in period:

• Nasal congestion scores are 2 or more and not all 4

• Patients with all nasal symptoms (sneezing, rhinorrhea, and nasal congestion). A total score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) and eye symptom is less than 6

• Patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptoms score is 4

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 392002	Koganei-Shi		Japan
2	Investigational Site Number 392003	Osaka-Shi		Japan
3	Investigational Site Number 392001	Shinjuku-Ku		Japan

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01306721
• Other Study ID Numbers: EFC11243; U1111-1115-7613
• First Posted: Mar 2, 2011
• Last Update Posted: Oct 16, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Fexofenadine; Pseudoephedrine; Ephedrine; Terfenadine

Study Results

No Results Posted as of Oct 16, 2013